Meet some of the expert presenters from BD, Aspen Research, Intertek, SGS, and more who brought innovative and industry-leading content to the 2021 Extractables and Leachables program.
Dr. David A Weil, is a master level scientist working for Agilent technologies since 2004, located in Wood Dale, IL. David Is married to his amazing with Naomi and has three older sons.
David’s research is focused on the application of high resolution mass spectrometry coupled with multidimensional separations techniques (GC, LC, and 2DLC, SFC, Ion Mobility) and advanced data mining software tools for multi-omics applications, in particular untargeted metabolomics linked back to changes in biochemical pathways. David is also the global technical leader for Agilent’s Extractable and Leachable analysis project, having developed an accurate mass database and MS/MS library for common E/L compounds. He is active in many collaborations with experts in the E/L field (e.g. Eli Lilly, BD, West Pharma, 3M, Jordi Labs, GE Healthcare, Eurofins, PPD) investigating how new technologies, software and workflows can advance the E/L. Prior to joining Agilent, Dr. Weil was the group leader of the 3M’s Corporate Research Analytical mass spectrometry group (1990-2004) responsible for characterization of extractable/leachable impurities present from a wide variety of drug delivery products including Meter Dose Inhalers, Transdermal Patches, Injectable products and Nasal/oral Sprays packaging
David received his Ph.D. from the University of Minnesota (1984) and Post Doc with Professor Charles Wilkins developing the precursor to MALDI.
Biography coming soon
Bryan Katzenmeyer has over 10+ years of experience specializing in mass spectrometry and separation techniques for the characterization of materials, polymers, monomers, and small molecules as well as increasing leadership roles within technical organizations. He currently oversees the Americas Materials Science business marketing segment for Waters Corporation. The Materials Science business market focuses on polymers, fine and specialty chemicals, extractables/leachables, medical device testing, cosmetics and personal care products, fuel/energy, and agrochemicals. Prior to joining Waters, Bryan was an Analytical Group Leader and Senior Scientist at Valspar (now part of Sherwin-Williams). While here he managed the liquid chromatography and mass spectrometry team focused on developing and validating analytical methodologies to characterize extractables and leachables, resins, oligomers, monomers, and other small molecules in packaging coatings for the food and beverage industries. Bryan received his Ph.D. in Polymer/Analytical Chemistry at The University of Akron working under Distinguished Professor Chrys Wesdemiotis. Here, he researched interfacing liquid chromatography and ion mobility separation with multi-dimensional mass spectrometry for the structural characterization of polymeric materials. He also obtained a M.S. in Chemistry from the University of Wisconsin-Madison and a B.S. in Chemistry from Penn State University.
Dr. Dujuan Lu serves as the manager for the extractables and leachables (E&L) team at the SGS Fairfield New Jersey facility as well as the global leader amongst the three centers of excellence for E&L testing. Before joining SGS, she worked at Fresenius Kabi as a research scientist, leading E&L projects to support transfusion and infusion medical device and parenteral products. She has extensive CRO and pharmaceutical/medical device industry experience with more than 500 E&L projects on a broad range of packaging systems, including process materials, pharmaceutical finished packaging, and medical devices. As a subject matter expert in the E&L field, she is frequently presenting at various conferences as invited speakers and technical session chairs. She was named one of the top 60 most influential people working in the pharmaceutical industry in the Medicine Maker’s 2020 power list.
Dr. Lu obtained her PhD in analytical chemistry from the University of Pittsburgh and BS in chemistry from Nanjing University. She has authored more than 15 high-impart journal publications with more than 300 citations. She is serving as an expert reviewer for more than 10 prestigious journals in the field of analytical chemistry and pharmaceutical science.
Dr. Pearson received his B.S. in Chemistry from Montana State University and his M.S. and Ph.D. in Environmental Chemistry from the University of Minnesota’s School of Public Health. Dr. Pearson joined Aspen Research in 1997 from a post-doctoral position at the University of Minnesota. His prior professional experience includes positions as a Research Chemist and Production Superintendent for Celanese Chemical Corporation. Dr. Pearson has extensive experience in gas chromatographic analysis of volatile and semi-volatile compounds, has coordinated many studies of off gassing phenomena at elevated process temperatures, and is an expert at coupling analytical results back to their process chemistry. He is an industry recognized expert in Extractables and Leachables techniques whose studies have been instrumental in assisting risk professionals in providing guidance for companies navigating in various regulatory arenas.
Bio Coming Soon
Theodore (Ted) Heise has three decades of experience in regulatory and clinical affairs, and currently serves as Vice President Regulatory and Clinical Services at MED Institute. In this capacity, Dr. Heise leads efforts to develop scientifically robust regulatory and clinical study strategies for the company’s clients: entrepreneurs, consultants and developers bringing new medical products through the complex steps of the development process.
Graduating Magna Cum Laude with a B.S. in chemistry from the University of Nebraska at Omaha, Dr. Heise went on to earn a Ph.D. in analytical chemistry from Iowa State University. He has been a member of the Regulatory Affairs Professionals Society since 1993, and the American Chemical Society since 1988.
For the past 12 years Dr. Heise has been a U.S. delegate to ISO TC 194, the technical committee for international consensus standards that govern biocompatibility testing and clinical investigations of medical devices. He currently serves as convenor of TC 194/WG 14. As convenor, Dr. Heise led the process of re-writing ISO 10993-18 to reflect current best practices in chemical characterization, including evaluation of extractables and leachables.
Dr. Cartledge is an associate research scientist with the extractables and leachables group at PPD® Laboratories in Middleton, Wisconsin. In 4 years at PPD, he has performed extractables and leachables studies including routine stability testing, controlled extraction studies, method development and validation, and medical device studies. He has successfully executed many programs leading to drug product approval by the FDA.
Kevin Rowland, M.S. received his bachelor’s degree in ceramic engineering in 2001 followed by a master’s degree in 2003 in materials science and engineering both from Alfred University. He then received a master’s degree in chemistry from Brown University under Dr. Brian Moulton in 2008 with research focusing on molecular self-assembly. Kevin has been at Jordi Labs for 11 years and has served as team leader for the GCMS and LCMS groups. His work has focused on interpretation of high-resolution accurate mass MS data for identification of non-target, unknown compounds. He is currently serving as Laboratory Manager.
Praneeth received his PhD in analytical chemistry from the University of Illinois at Chicago. He has been responsible for the design and execution of E/L studies and impurity identification with a focus on the use of mass spectrometry. Praneeth has more than two decades of experience in the area of analytical mass spectrometry both in the pharmaceutical and chemical industry. Praneeth has performed extensive research in the drug discovery field as a postdoctoral fellow as well as NIH fellow. He has several publications and patents.
Dr. Alan Hendricker has 15 years of experience in extractables and leachables analysis and 25 years of experience with mass spectrometry. He received his undergraduate degree from Ohio University and Ph.D. from the Colorado School of Mines in 1999. He was a co-author on the PQRI Working Group on Leachables and Extractables recommendation “Safety Thresholds and Best Practices for Leachables and Extractables in Orally Inhaled and Nasal Drug Products (OINDPs).” He has been an active member of the PQRI Leachables and Extractables Parenteral Ophthalmic Drug Product (PODP) working group. He has written and presented extensively on extractables and leachables issues. Alan was a member of the Structural Chemistry Group at Magellan Laboratories through its acquisitions by Cardinal Health and subsequent purchase by the Blackstone Group as Catalent Pharma Solutions. Since January of 2014, Alan works at Becton Dickinson (BD) as part of the corporate preclinical development group on extractables and leachables studies for BD devices and products.
Bio Coming Soon
Currently a Staff Scientist with AstraZeneca in the Research Triangle Park (RTP) working on extractables and leachables (E&L). I have been in the field since 2001. I began my E&L career extracting and analyzing flavor compounds from soy protein. In 2005 I began to work with pMDI container closure systems. Currently manage the E&L activities at RTP and support other R&D groups within AstraZeneca. A member of the Materials Working Group within ELSIE and Knowledge Base sub-team I have been supporting the development of an extractables knowledge base. A member of the IPAC-RS Materials working group and involved with defining medical grade plastics and bio-compatibility. I have a Ph.D. in Physics from the University of Wyoming.
Dr Andrew Feilden joined Hall Analytical in November 2019 as the European E&L Strategic Director. He is a technical expert in the field of E&L testing, having been involved in the field of E&L for over 20 years. At Hall he undertakes Commercial, Operational and technical thought leadership activities.
Andrew has presented on the field of extractables and leachables in over 16 countries worldwide. He has written a number of papers and publications and is the inventor of 2 patents.
He has a degree and D Phil from the university of York, is a Fellow of the Royal Society of Chemistry and was a Scientific Advisor to IPAC-RS and ex-co-chair of ELSIE.
As general manager, Paul is responsible for the Smithers Analytical Services lab located in Akron to support extractables and leachables studies for the medical device, pharmaceutical and food industries. The lab also provides chemistry support to Smithers existing analytical and physical testing laboratories.
Paul’s specialty areas of expertise include mass spectrometry with a significant background in small molecule structure elucidation. He also has extensive experience in extractables and leachables and other areas of packaging testing such as container closure integrity.
Paul brings over 35 years of experience in chemistry and leadership in the pharmaceutical industry. Most recently he was a Research Fellow and Manager of Trace Organic Analysis for Intertek Pharmaceutical Services. He has also worked at West Pharmaceutical Services, Drugscan, GlaxoSmithKline and Merck.
Paul holds a Bachelor of Science degree in Chemistry from Old Dominion University and a Master of Science Degree in Analytical Organic Chemistry from Villanova University. He also served his country in the United States Army.
Douglas Kiehl is a Research Advisor at Eli Lilly and Company and leads the Advanced Structural Characterization, Trace Analysis, Extractables/Leachables and Elemental Impurities team. With over 38 years' experience with application of advanced mass spectrometry in characterization of diverse chemical entities, 26 years in the Pharmaceutical Industry. He is a member of the USP Packaging and Distribution Expert Committee, Vice Chair for the PQRI (Product Quality Research Institute) Development Technical Committee, PhRMA Topic Lead for the ICH Q3E Expert Working Group, the USP Expert Panel on Biocompatibility of Materials Used in Packaging Systems, Medical Devices and Implants, the USP Expert Panel on Elastomeric Closure for Injections, Board of Directors for the ELSIE Consortium, Chair for the SPIE Defense and Commercial Sensing Conference and member of the AAPS Impurities Steering Committee. His research interests include the development of advanced mass spectrometry-based mapping and visualization techniques to enable the rapid and comprehensive characterization of highly complex mixtures of structurally and compositionally diverse chemical entities. He also leads multidisciplinary efforts to advance ultrarapid threat detection and development, manufacture and deployment of pharmaceutical countermeasures for catastrophic (e.g. pandemic, environmental disaster, etc.) unanticipated medical needs and point-of-use patient therapies.
Ward D’Autry is study director structural elucidation at Nelson Labs, where he manages projects related to the identification of unknowns using high-end mass spectrometry platforms. Mr. D’Autry received his Ph.D. from the Laboratory for Pharmaceutical Analysis, Faculty of Pharmaceutical Sciences of the University of Leuven (Belgium) in 2010. From 2010 to 2017 he worked for DSM and SABIC in Geleen, The Netherlands, where he worked as R&D scientist developing and optimizing chromatography & mass spectrometry based analytical methods for improved analysis of (complex) petrochemical samples or polymeric systems. Often the work included de novo interpretation of mass spectral data.
From 2017 onwards, Mr. D’Autry works for Nelson Labs Europe as study director extractables & leachables. Until recently, he managed extractables & leachables studies with focus on manufacturing components. In 2021 he transitioned to his current role as study director structural elucidation.
Lee M. Nagao, Ph.D., is a Senior Director of Science, Regulation and Policy at the law firm of Faegre, Drinker, Biddle and Reath, LLP, and is a member of the Firm’s Life Sciences Consortium Management and Regulatory Affairs Practice Group. The Group works extensively with pharmaceutical, biopharmaceutical and medical device companies on a range of scientific and regulatory collaborations and provides strategic and regulatory guidance to individual life sciences companies. Lee plays a lead role serving scientific and regulatory consortia including the International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS), the Extractables and Leachables Safety Information Exchange (ELSIE), and the International Pharmaceutical Consortium on Innovation and Quality (IQ). Lee has extensively published and presented on many aspects of pharmaceutical development including supply chain, CMC, and translational sciences. She has represented various industry groups before regulatory and scientific agencies and organizations in the US, Europe and Asia, including the FDA, EMA, China NIFDC, Chinese Pharmacopoeia, ANVISA, Taiwan CDE, Japan PMDA, and USP.
Dr. Stanard is currently the Director, EHS Product Stewardship at Ultragenyx and previously lead Global Occupational & Quality Toxicology at AstraZeneca. Dr. Stanard has over 20 years of experience in the biopharmaceutical industry covering a broad spectrum of responsibilities in the drug development process within R&D, clinical and commercial manufacturing operations. During this time, his primary focus has been on hazard identification and hazard/risk assessment, including occupational exposure limits and derivation of daily exposure values for extractables and leachables, APIs, intermediates and impurities. Dr. Stanard received his PhD in toxicology from Colorado State University and an MPH in toxicology from San Diego State University. He is a Diplomat of the American Board of Toxicology. Dr. Stanard is an active member of the Extractables and Leachables Safety Information Exchange (ELSIE), serving as the co-chair of the Safety Working Group and member of the Executive Committee and Board of Directors.
Diane Paskiet has over twenty-five years of experience in the pharmaceutical industry. She is currently Director of Scientific Affairs at West Pharmaceutical Services where she is involved in science and regulatory programs associated with safety and compatibility of pharmaceutical packaging and delivery systems. Previous to this role she was in charge of site operations for West-Monarch Analytical Laboratories. She is Chair of Product Quality Research Institute (PQRI) Development Technical Committee (DTC) and the Extractables and Leachables Parenteral Drug Product Working Group. Diane is also on the faculty of the Parenteral Drug Association Training Institute and a Board Member of Xavier Health Innovation Training Center of Excellence (ITCE). She has author/co-author a number of papers and book chapters related to pharmaceutical packaging, delivery systems and combination products.
Gyorgy Vas has over 20 years of experience in scientific research, product development, and laboratory management. Much of that time has been spent in a cGMP environment, where he has provided his expertise to solve problems related to finished pharmaceutical products and medical devices.
In his current position, he advises on regulatory filing strategies for multiple clients, and his group provides solutions for mitigating deficiency letters. Gyorgy led the implementation of state-of-the-art solventless sample preparation techniques into the cGMP laboratory processes, and is one of the few in this field with expertise in method development and validation for ultratrace (parts-per-trillion) level impurities in finished pharmaceutical products and medical devices.
Andy Leightner has over 10 years of experience serving the pharma market from contract research organizations. He specialized in method development and validation leveraging LC, GC, and mass spectrometry to meet client needs. He currently supports the Americas pharmaceutical business marketing segment for Waters Corporation. The pharmaceutical business market focuses on small and large molecule discovery, development and QC including: ADME, DMPK, bioanalysis, characterization, E&L, method development & validation, MLCM, lot release, and storage stability. Andy received a bachelors degree in biology from the University of Wisconsin-Madison.
Dr. Saylor has been a staff member at the US Food and Drug Administration for the past 17 years in the Division of Biology, Chemistry and Materials Science (DBCMS) within the Office of Science and Engineering Laboratories (OSEL) in the Center for Devices and Radiological Health (CDRH). At the USFDA, he has pursued research in the area of theoretical and computational materials science applied to medical device applications. These efforts have focused on the dynamics of medical device material systems and tissue interactions at multiple length scales: atomistic/molecular, microstructural, and device scales. This research has addressed a variety of premarket and postmarket issues for medical devices, including the impact of manufacturing changes and tissue composition on the performance of controlled drug release systems, the release and retention of nickel in patients implanted with nickel-containing alloy devices, and patient exposure to potentially toxic additives in biomedical plastics.
Born: 10.09.1981 in Piekary Śląskie, Poland
Alicja is currently employed at the Octapharma where she is responsible for material qualification at corporate level including chemical safety assessment of polymerc processing, packaging, and administration materials and the planning and supervision of extractables and leachables studies.
Prior to joining Octapharma, Alicja had a tenured position as a researcher at the French National Institute for Agricultural Research (INRA) where she investigated various possibilities to increase sustainability in the food processing industry. Alicja has compelled broad experience in material and polymer science and technology at the Institute for Composite Materials (IVW) in Kaiserslautern as well as at the Centre for Neutron Science (JCNS) and at the Institute for Nuclear Waste Disposal and Nuclear Safety (IEK-6) at the Research Centre in Jülich, Germany.
Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein manufacturers in the world, developing and producing human proteins from human plasma and human cell lines. As a family-owned company, Octapharma believes in investing to make a difference in people’s lives and has been doing so since 1983; because it’s in our blood. Octapharma owns five state-of-the-art production facilities in Austria, France, Germany, Mexico and Sweden. For more information visit www.octapharma.com.
Biography coming soon.
Anna Michelson Ph.D., Gyorgy Vas Ph.D., Louis Fleck, John Duett, Nan Zhang, Jacquelyn Cali
Intertek Pharmaceutical Services, Whitehouse NJ
Choice of extraction technique is often critical for the outcome of an extractable study. Chromatographic profiles for various extraction techniques (closed pressurized vessel (CPV), temperature controlled orbital shaker, accelerated solvent extraction (ASE), reflux) are compared.
In addition, importance of high resolution instrumentation for proper identification is highlighted for GC-MS and LC-MS data.
